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Bringing the Band Back Together

Return of the LAP-BAND

Approved by the FDA in 2001, the LAP-BAND® System has been hailed by some as the device that brought bariatric surgery to the masses and by others as an example of market abandonment. Over the last 18 years, the device has had a roller coaster ride from boasting sales in excess of US$280 million to being much maligned and sold three times. Now, the device has landed back into the lap of the very person who first led commercialization of the device nearly two decades ago, Mr Bart Bandy, President and Chief Executive Officer of ReShape Lifesciences™.

At the recent IFSO meeting in Madrid, Spain, Bariatric News talked to Mr Bandy, who outlined why he believes the LAP-BAND System is still as relevant now as it was nearly 20 years ago, dispelled some of the myths surrounding the device and explained why he is re-uniting with some of his previous colleagues to reinvigorate the new team behind the LAP-BAND, and is in his own words, “Bringing the band back together!”

“The LAP-BAND was started by a small group of people and I came in to front the commercial programmes at Inamed in 1999. At the time, everyone else in the company was either regulatory or engineering and I was initially tasked with building up international distributors and marketing,” he began. “We developed close relationships with our first surgeons, they were as excited about the product as we were and could see its potential. It required a great deal of dedication and hard work as we had limited resources and the need to get good clinical evidence that the product was safe and effective. A couple of years later, we received FDA approval and then we worked on getting reimbursement with the local, regional and national insurers which required incredible commitment of additional time and resources.”

In 1999, there were approximately 25,000 bariatric procedures performed in the US and, according to Mr Bandy, within a few years the LAP-BAND played a significant role in increasing the total number of procedures to over 200,000 per year - in part by demonstrating that this lower-risk, anatomy-sparing and removable device implanted via a minimally invasive procedure was an effective and desirable alternative, especially in the eyes of the public.

“We are reaching out to the surgeons that used the LAP-BAND and saying, we are back and here to work with you. We need to reach out to new surgeons and provide professional education opportunities and we need to reach out to patients and communicate that the LAP-BAND is a procedure that has more than 20 years of durability with a compelling safety and efficacy profile.”

“Patient awareness has always had a huge impact on bariatric surgery, which is perhaps unique compared to other specialties, we didn’t just have to engage the surgeons, but also the potential patients. It might be different now with the internet, but at the time the average person didn’t know the difference between a gastric bypass or sleeve gastrectomy – they just knew it as ‘stomach stapling’ – and that scared many of them,” he explained. “Adjustable gastric banding offered them a less frightening surgical option, that was customizable and reversible – something that you could not do with a gastric bypass or sleeve gastrectomy. Patients knew that if a complication occurred you could adjust the LAP-BAND or take it out. The LAP-BAND is something that can work with you, it was not about ‘curing’ the patients with a stand-alone surgery, but treating the individual by helping them to tame their hunger by feeling satiated sooner and longer. The patients wanted to be in control and with the LAP-BAND, and with committed clinical and behavioural support they were.”

In 2006, Inamed was bought by Allergan who initially oversaw a huge increase in LAP-BAND sales through their expansive resources and expertise in consumer marketing. Mr Bandy left Allergan in 2008 after leading that transition. Five years later, Allergan sold its obesity intervention division (comprising of the LAP-BAND and ORBERA intra-gastric balloon systems) to Apollo EndoSurgery. In December 2018, Apollo announced that it was selling the LAP-BAND to Reshape Lifesciences, who announced the appointment of Mr Bandy as President and CEO in April this year.

“In my opinion, the LAP-BAND went to a couple of companies that were not truly focused on it and like any technology, if you don’t promote it, don’t maintain your customer base and don’t train new surgeons how to use the product - people will lose interest, competitive alternatives will prosper and the product will wither. The fact the product is still around today - after declining attention over the past years – is a testament to its viability.”

“I spoke with a number of surgeons who still use the LAP-BAND and others who no longer use it to try and understand what had happened. A few indicated that they had not seen a company representative in several years, so if they wanted to buy the product they weren’t even sure who to call. The importance of patient marketing also stood out as accounts not promoting the product had not seen any patients requesting the LAP-BAND, yet many still wanted to use it, especially for specific cases.”

“I grew up in the bariatric speciality, I have many lifelong friends here and there has always been something special about this industry. I observed the first Laparoscopic Gastric Bypass case with Drs. Wittgrove and Clark, supporting the instruments of my then company. It has been my honour to be the first Chairperson of the ASMBS Corporate Council and to have worked with the leading bariatric surgeons across the globe. My wife worked for many years running a bariatric practice development company, so for us it was like coming home. After leading the initial growth of the LAP-BAND, I feel like many others in that the product we loved so much has not had the same level of care for a while. So now, we are building a great team of people with significant experience, renewed passion and strong professional relationships - to get it back on track.”

“The LAP-BAND still has the same solid technological foundations that it was based on, we are currently evaluating some newer technology that we may incorporate into and around the device. These updates will address some of the potential areas for improvement that surgeons have expressed, including patient tolerance, patient management and aftercare. While some patients like the idea of going back to see their caregiver for follow-up, other patients not so much. So, we need to make the LAP-BAND more attractive to all of our customers while remaining focused on optimal outcomes.”

“Some people say the LAP-BAND is not effective in the long-term, that is simply untrue. There are several published studies reporting weight loss at five, ten, 15 and 20 years. Other reports claim that the LAP-BAND has a high removal rate – again, recently published research does not reflect this."

“If you look at the more recent developments in the bariatric market, such as endoscopic plication or gastric space-filling technologies, they are trying to develop procedures that are at the low-risk end of the continuum, but none of them have really captured any significant market share, in part due to reimbursement. This also validates the function and importance of the LAP-BAND as a reimbursed option for practices and patients. It is similar to a golfer having particular clubs for a specific purpose, but the LAP-BAND is not just another club, it is one that they have used in the past and know that it has worked well. Lower BMI patients, younger patients and patients who may become pregnant are some of the demographics where surgeons may find our technology highly applicable.”

“We are reaching out to the surgeons that used the LAP-BAND and saying, we are back and here to work with you. We need to reach out to new surgeons and provide professional education opportunities and we need to reach out to patients and communicate that the LAP-BAND is a procedure that has more than 20 years of durability with a compelling safety and efficacy profile.”

Dispelling the myths

He stated that the LAP-BAND has had a lot of unfair and negative publicity over the last few years, many were blatantly false.

“There is no perfect bariatric procedure, they all have their advantages and disadvantages and some may work better for individual patients than others. We need different procedures for different patients and the LAP-BAND is an established option."

“Some people say the LAP-BAND is not effective in the long-term, that is simply untrue. There are several published studies reporting weight loss at five, ten, 15 and 20 years. Other reports claim that the LAP-BAND has a high removal rate – again, recently published research does not reflect this. We recognize that the market is seeing a generation of surgeons who - through no fault of their own do not have the necessary training or experience on how to manage LAP-BAND patients. So instead of seeking the advice of a more experienced colleague or generating a referral to a LAP-BAND practice, they tell the patients the “Band” has failed and offer them an alternative procedure. We have also been informed by clinical experts that while many of these bands could be adjusted or repositioned, they are often removed for no valid device-related reason.”

According to Mr Bandy, there has been a one-sided conversation for nearly a decade with detractors throwing rocks at the LAP-BAND and many surgeons reluctant to throw rocks back without the feeling of support from their peers and a company. He added that it is important for surgeons to know that he and his team are behind them, with their experience and full commitment. This was recently illustrated during a ReShape Lifesciences meeting prior to the IFSO Congress. In the room, 30 employees and distributors accounted for over 250 years of direct experience with the LAP-BAND. Beyond providing expert support, ReShape Lifesciences will continue to gather clinical data to validate LAP-BAND safety and efficacy claims, while additionally supporting clinical studies that further dispel negative myths in reference to their technology.

“There is no perfect bariatric procedure, they all have their advantages and disadvantages and some may work better for individual patients than others. We need different procedures for different patients and the LAP-BAND is an established option. There are many indications that may favour the LAP-BAND compared with more invasive procedures, but we are not going to start slinging mud about other procedures, all procedures have their place and attacking each other brings down the industry as a whole. We just want a fair and healthy environment where people can objectively evaluate our technology, clinical outcomes and true potential to help more patients improve their lives.”

Gastric Vest

In addition to the LAP-BAND, ReShape Lifesciences also has a second budding technology, the Gastric Vest System, which recently began the ENDURE II clinical trial designed to support CE Marking of the Gastric Vest in Europe.

The Gastric Vest is an investigational, minimally invasive, laparoscopically implanted medical device being assessed for weight loss in patients with obesity and morbid obesity. The device wraps around the stomach, emulating the effect of more aggressive weight-loss surgery, and enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the US, at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Haemoglobin A1c) of 2.1 points and an average waist circumference reduction of 38 cms.

“The Gastric Vest System is very similar to the LAP-BAND in that is a minimally invasive procedure, reversible and does not change the anatomy of the patient’s body – but does not require the same type of aftercare. The Gastric Vest is not going to replace the LAP-BAND, but will hopefully become another great addition to our product portfolio.”

He added that in some way history is repeating itself, 20 years ago the LAP-BAND started off with a small group of surgeons who gradually performed more and more LAP-BAND procedures, carried out clinical evaluations and then published their data. “Our focus will be to work closely with the foremost surgeons in providing optimal outcomes for patients, promoting the brand, conducting clinical studies and publishing results. This straightforward strategy worked quite well the first time and we are confident it will work for a second time as well.”

ObesityWeek 2019

ReShape Lifesciences will be attending ObesityWeek 2019, taking place at the Mandalay Bay Resort in Las Vegas, Nevada, from November 3-7, 2019. The LAP-BAND® by ReShape Lifesciences™, which has nearly one million placements around the world, will be highlighted at the company's booth in the exhibit hall of the conference, where senior company representatives will be meeting with key clinical opinion leaders to discuss ReShape Lifesciences' commitment to its existing and emerging bariatric surgery technologies. In conjunction with the conference, ReShape Lifesciences will be one of the sponsors of the ASMBS Foundation's 2019 Gala & LEAD Award Event and will present a special-invitation-only program that will review long-term data on the demonstrated safety and efficacy profiles of the LAP-BAND System. Details are below:Tuesday, November 5
7:00 - 8:30 pm: "Dispelling LAP-BAND® Myths" Presented by Vincent Lusco III, MD, General and Bariatric Surgeon at LapBand of Louisville Surgical Associates and Keith E. McEwen, MD, Bariatric Surgeon at Community Health Network in Noblesville, Indiana. This session will be held at the Delano Hotel, 3940 S. Las Vegas Blvd. in Las Vegas, Nevada in the Indigo BC Room.